Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases

NCTNCT00081159 (opens ClinicalTrials.gov in a new tab)Other id2003-0922Other idMDA-2003-0922Other idNCI-6459Other idNCI-2009-00062

Overview

Status
Completed
Phase
Phase 2
Enrollment
80 participants (actual)
Sponsor
M.D. Anderson Cancer Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jul 2004
Primary completion
Sept 2014
Completion
Sept 2014
First posted
8 Apr 2004 (estimated)
Last update posted
10 Nov 2016 (estimated)
Conditions
Metastatic Cancer · Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420062008201020122014
  1. Ph 2

    Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases

    NCT00081159

    Jul 2004 to Sept 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and leuprolide may fight prostate cancer by stopping the adrenal glands from producing androgens. Drugs used in chemotherapy such as doxorubicin work in different ways to stop tumor cells from dividing so they stop growing or die. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. It is not yet known whether hormone (androgen) ablation therapy and chemotherapy combined with zoledronate is more effective with or without strontium-89 in treating prostate cancer and bone metastases. PURPOSE: This randomized phase II trial is studying giving hormone ablation therapy, doxorubicin, and zoledronate together with strontium-89 to see how well it works compared to hormone ablation therapy, doxorubicin, and zoledronate alone in treating patients with androgen-dependent prostate cancer and bone metastases.

Interventions

  • Doxorubicin hydrochlorideDrug
  • Goserelin acetateDrug
  • Leuprolide acetateDrug
  • Zoledronic acidDrug
  • orchiectomyProcedure
  • strontium chloride SrRadiation

Arms2

  • Experimental

    HAT, Doxorubicin, Zoledronate + Strontium chloride

    Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.

  • Experimental

    HAT, Doxorubicin + Zoledronate

    Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Progression Free Survival (PFS)

    Time frame · Up to 90 months with evaulation in 4 week intervals for up to 6 months of treatment, then follow up until disease progression

    Registry description

    Study's primary endpoint of PFS duration/time to progression was defined as the time from the date of randomization to the date of first evidence of disease progression or patient death. Prostate-specific antigen (PSA) progression is usually the first evidence of progression. PSA progression is defined as a 25% increase over the baseline or the nadir provided that the increase is a minimum of 1 ng/ml.

Secondary outcomes(1)
  1. Major Bone Scan Response

    Time frame · Week 13

    Registry description

    Bone scan performed at baseline and at Week 13 provided if baseline scan was positive for metastases. A major bone scan response was considered with a substantial resolution of participant bone metastases on the bone scans, i.e. complete resolution of the osseous metastases on the bone scan.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Up to 90 months with evaulation in 4 week intervals for up to 6 months of treatment, then follow up until disease progression

Progression Free Survival (PFS)

GroupValue (Months)
HAT, Doxorubicin, Zoledronate + Strontium Chloride12.9
HAT, Doxorubicin + Zoledronate18.5
Secondary and other outcome results(2)
Secondary outcomeNumber· Week 13

Major Bone Scan Response

GroupValue (participants)
HAT, Doxorubicin, Zoledronate + Strontium Chloride0
HAT, Doxorubicin + Zoledronate0
Other pre specified outcomeMedian· Up to 90 months

Overall Survival (OS)

GroupValue (Months)
HAT, Doxorubicin, Zoledronate + Strontium Chloride47.4
HAT, Doxorubicin + Zoledronate53.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
HAT, Doxorubicin, Zoledronate + Strontium ChlorideArm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.–0 / 3924 / 39
HAT, Doxorubicin + ZoledronateArm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.–0 / 3729 / 37

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Histologically or cytologically confirmed prostate carcinoma. 2. Osteoblastic metastases on bone scan or computed tomography (CT) scan. 3. Initiation of hormonal ablative therapy within 3 months of registration. 4. Prior neoadjuvant, concurrent, or intermittent hormonal ablative therapy of less than 3 years duration and completed at least 3 years prior to entry into this study. 5. The Eastern Cooperative Oncology Group (ECOG) performance status \<3 (Karnofsky \>40%) 6. Patients must have normal organ and marrow function as defined: leukocytes: \>3,000/mL; absolute neutrophil count: \>1,500/mL; platelets: \>100,000/mL; total bilirubin within normal institutional limits; alanine transaminase (ALT)(SGPT)/aspartate aminotransferase (AST)(SGOT): \<2.5 \* institutional upper limit of normal; creatinine: \< or = 3.0; left ventricular ejection fraction: \>45% 7. The effects of strontium-89 and zoledronic acid on the developing human fetus at the recommended therapeutic dose are unknown. Even though all patients are castrated during this study, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should the spouse of a patient become pregnant or suspect she is pregnant while participating in this study, she/he should inform the treating physician immediately. 8. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. More than one prior chemotherapy regimen. Prior doxorubicin treatment is permitted. However patient's with \>250 mg/m2 cumulative dosage are excluded. 2. Prior radioisotope treatment consisting of strontium-89 or samarium-153. 3. Zoledronic acid treatment for more than 3 months duration prior to registration. Other bisphosphonate treatments are permitted. 4. Corrected serum calcium level less than 8 mg/dL. 5. Patients may not be receiving any other investigational agents. 6. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to zoledronic acid or other agents used in the study 8. Patients with the following atypical presentations should have a biopsy: those with small cell carcinoma, purely lytic bone metastases, or bulky (i.e. 5 cm) visceral or nodal disease in the absence of bone involvement are not eligible. 9. Symptomatic bulky lymphadenopathy causing scrotal or pedal edema or significant local invasive disease in bladder invasion. 10. History of other malignancies other than nonmelanoma skin cancer, unless in complete remission and off therapy for that disease for at least 5 years. 11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 12. Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with strontium-89 or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated. 13. Evidence or suspicion of myelodysplastic syndrome by complete blood test (CBC) must be confirmed by bone marrow biopsy. 14. Untreated symptomatic spinal cord compressions.

PepBank is a research reference. Talk to a doctor before you use any peptide.